Vitamin D3 DeficiencyNCT03417700
Vitamin D as a Factor Modifying Adaptation to Exercise
A study testing NW training and HICT in people with Vitamin D3 Deficiency, run by Gdansk University of Physical Education and Sport at 2 sites in Poland.
Trial summary
Physical activity is a recommended, indispensable element of a healthy lifestyle as well as a countermeasure against many diseases often accompanied by the acute or chronic low grade inflammation. Papers published in recent years have demonstrated the anti-inflammatory effect of exercise. Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D3 Deficiency
- What is being tested?
- NW training and HICT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesPoland
- Study dates
- 5 Jan 2018to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- no illness medical check
Who cannot join
- uncontrolled hypertension (diastolic blood pressure over 100 mmHg), a history of cardiac arrhythmia, cardio-respiratory disorders, advanced osteoporosis, clinical diagnosis of Alzheimer's Disease
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336
Ziemann Ewa
Sopot, Pomeranian Voivodeship, 81-735
About this study
Official title: Vitamin D as a Factor Modifying Adaptation to Diverse Forms of Exercise
Physical activity is a recommended, indispensable element of a healthy lifestyle as well as a countermeasure against many diseases often accompanied by the acute or chronic low grade inflammation. Papers published in recent years have demonstrated the anti-inflammatory effect of exercise. Based on current knowledge of the topic, own experience and preliminary work, it is expected the proposed research to provide information on the mechanism either determining or limiting pro-healthy effects of exercise in different age groups of people. Three different training programmes will be investigated. Specific goals of the project include the following:
- Establish, whether regular Nordic Walking training and HIIT can reduce the low-grade systemic inflammation and which type of training is the most effective at doing so.
- Establish, whether regular training can prevent muscle sarcopenia and assess if those changes are related to the concentration of the autophagy-inducing stress protein, HMGB1.
- Establish, whether regular Nordic Walking training alters iron metabolism and evaluate its correlation with the inflammatory markers and bone-morphogenesis.
- Establish, whether muscle-released irisin signals growth in the BDNF concentration in response to exercise and if these changes improve cognitive function.
- Establish, whether Nordic Walking or HIIT training effectively improve the blood lipid profile and aerobic capacity, and if these effects correlate with the blood 25-OHD concentration.
- Establish, whether concentration of vitamin D alters adaptation to training and modifies immunological response to regular training process.
Read the detailed description
The mechanism behind the anti-inflammatory effect of exercise is not fully understood. In some cases physical activity has proven almost/completely ineffective in reducing systemic inflammation. Thus, evaluating factors, which modify this response, is of particular significance. One of them may be related to iron metabolism. It is has been suggested that regular training reduces body iron stores, which can contribute to the anti-inflammatory response. Consequently, one of the anti-inflammatory effects of exercise can be related to changes in iron metabolism. Nevertheless, our preliminary data demonstrated that eight months of Nordic Walking training did not reduce body iron stores in approx. 25% of subjects, even if some of them were characterized by high blood ferritin (good indicator of body iron stores). This may be related to the effect of exercise on the concentration of hepcidin (main regulator of iron absorption, which acts as a negative regulator of iron efflux). It is well documented that a single bout of exercise induces an increase in blood hepcidin; however, data on the effect of regular training on the hepcidin concentration are limited.
Vitamin D is another factor, which could influence the anti-inflammatory effect of exercise. It has been suggested that individuals involved in physical activity have higher concentrations of 25OHD (indicator of vitamin D status). Vitamin D inhibits the expression of pro-inflammatory cytokines, which is considered the main mechanism of its anti-inflammatory action. It is worth noting that population in Poland is characterized by low status of vitamin D. Thus, it is possible that the anti-inflammatory effect of exercise will be modified by the vitamin status. Moreover, vitamin D has been shown to protect against muscle atrophy both in elderly and younger people. Its concentration has been correlated with muscle strength.
Inflammation has been observed to be associated with an increase of the autophagy-inducing stress protein, HMGB1, which mediates muscle atrophy. Measurement of plasma amino acid profile will be helpful to assess the impact of exercise on muscle proteolysis. Moreover, the link between exercise, vitamin D status and HMGB1 has not yet been established. In addition, a range of interactions induced by exercise involves the release of the newly discovered protein, irisin, form the muscle and its improving effect on the cognitive function through the synthesis of brain-derived neurotrophic factor (BDNF). Data on the effect of regular training on irisin concentration in elderly people is lacking.
Overall, our research interest focuses on the role of the factors mediating the anti-inflammatory effect of exercise and the way they stimulate or inhibit adaptive changes. The proposed project draws on our long experience in investigating the effects of exercise on iron metabolism as well as other physical methods supporting the anti-inflammatory action of physical activity. Latest published papers indicate that the concentration of vitamin D, also in training adaptation, can modulate immunological response to exercise. Therefore, verifying our hypothesis would also allow us to determine if the concentration of vitamin D can limit adaptation to physical activity.
- Conditions
- Vitamin D3 Deficiency
- Being tested
- NW training, Placebo, HICT
- Keywords
- vitamin D, exercise, training, aging
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NW trainingDietary supplement
Also called Training, vitamin D
NW training
PlaceboDietary supplement
Also called Control group
training with placebo
HICTDietary supplement
Also called resistance training
Training and vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Training NW | Experimental | exercise and supplementation Receives: Dietary Supplement: NW training; Dietary Supplement: Placebo |
| Training HICT and vitamin D | Experimental | Training HICT plus vitamin D Receives: Dietary Supplement: NW training; Dietary Supplement: Placebo; Dietary Supplement: HICT |
| Placebo | Experimental | placebo Vitamin D Receives: Dietary Supplement: NW training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The influence of vitamin D on physical performance in aging people
To verify if training supported by vitamin D supplementation will bring better effects
Measured: Values at baseline will be compared to values recorded 12 weeks and 3 months after the training programme.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start5 Jan 2018
- Primary completion1 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vitamin D3 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Model I Women and men over 65 years old will participate in the training programme. All subjects will undergo a medical check-up before being subject to exercise. All procedures will be performed with the approval from the Bioethical Committee of the Regional Medical Society in Gdansk. One week prior to the beginning of the experiment, a battery of physiological and psychological tests will be performed. The same procedure will be repeated after the training period. In addtition to training, supplementation of vitamin D (800IU and 4000IU) will be administered. Model II Young women will participate in the training programme. They will perform a high-intensity circuit training according to the ACSM. They will perform a single session of HICT and 12 units of HICT regularly. One week prior to the beginning of the experiment, a battery of physiological and psychological test will be performed. The same procedure will be repeated after the training period.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Olek, Gdansk University of Physical Education and Sport
- Investigators
- Ewa Ziemann, Principal investigator, Gdansk University of Physical Education and Sport, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417700
- Sponsor's protocol ID
- 2014/15/B/NZ7/00976
- Status last verified
- May 2021
- First submitted
- 30 Nov 2017
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Written-up results of research will be submitted for publication to international journals.
Publications
Gmiat A, Mieszkowski J, Prusik K, Prusik K, Kortas J, Kochanowicz A, Radulska A, Lipinski M, Tomczyk M, Jaworska J, Antosiewicz J, Ziemann E. Changes in pro-inflammatory markers and leucine concentrations in response to Nordic Walking training combined with vitamin D supplementation in elderly women. Biogerontology. 2017 Aug;18(4):535-548. doi: 10.1007/s10522-017-9694-8. Epub 2017 Mar 18.
PubMed 28316011Prusik K, Kortas J, Prusik K, Mieszkowski J, Jaworska J, Skrobot W, Lipinski M, Ziemann E, Antosiewicz J. Nordic Walking Training Causes a Decrease in Blood Cholesterol in Elderly Women Supplemented with Vitamin D. Front Endocrinol (Lausanne). 2018 Feb 20;9:42. doi: 10.3389/fendo.2018.00042. eCollection 2018.
PubMed 29515518Walentukiewicz A, Lysak-Radomska A, Jaworska J, Prusik K, Prusik K, Kortas JA, Lipinski M, Babinska A, Antosiewicz J, Ziemann E. Vitamin D Supplementation and Nordic Walking Training Decreases Serum Homocysteine and Ferritin in Elderly Women. Int J Environ Res Public Health. 2018 Sep 20;15(10):2064. doi: 10.3390/ijerph15102064.
PubMed 30241318Mieszkowski J, Niespodzinski B, Kochanowicz A, Gmiat A, Prusik K, Prusik K, Kortas J, Ziemann E, Antosiewicz J. The Effect of Nordic Walking Training Combined with Vitamin D Supplementation on Postural Control and Muscle Strength in Elderly People-A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Sep 7;15(9):1951. doi: 10.3390/ijerph15091951.
PubMed 30205445Gmiat A, Jaworska J, Micielska K, Kortas J, Prusik K, Prusik K, Lipowski M, Radulska A, Szupryczynska N, Antosiewicz J, Ziemann E. Improvement of cognitive functions in response to a regular Nordic walking training in elderly women - A change dependent on the training experience. Exp Gerontol. 2018 Apr;104:105-112. doi: 10.1016/j.exger.2018.02.006. Epub 2018 Feb 9.
PubMed 29432893Kortas J, Kuchta A, Prusik K, Prusik K, Ziemann E, Labudda S, Cwiklinska A, Wieczorek E, Jankowski M, Antosiewicz J. Nordic walking training attenuation of oxidative stress in association with a drop in body iron stores in elderly women. Biogerontology. 2017 Aug;18(4):517-524. doi: 10.1007/s10522-017-9681-0. Epub 2017 Feb 22.
PubMed 28229255
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D as a Factor Modifying Adaptation to Diverse Forms of Exercise
- ClinicalTrials.gov ID
- NCT03417700
- Acronym / sponsor ID
- 2014/15/B/NZ7/00976
- Conditions
- Vitamin D3 Deficiency
- Keywords
- vitamin D, exercise, training, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical activity is a recommended, indispensable element of a healthy lifestyle as well as a countermeasure against many diseases often accompanied by the acute or chronic low grade inflammation. Papers published in recent years have demonstrated the anti-inflammatory effect of exercise. Based on current knowledge of the topic, own experience and preliminary work, it is expected the proposed research to provide information on the mechanism either determining or limiting pro-healthy effects of exercise in different age groups of people. Three different training programmes will be investigated. Specific goals of the project include the following:
- Establish, whether regular Nordic Walking training and HIIT can reduce the low-grade systemic inflammation and which type of training is the most effective at doing so.
- Establish, whether regular training can prevent muscle sarcopenia and assess if those changes are related to the concentration of the autophagy-inducing stress protein, HMGB1.
- Establish, whether regular Nordic Walking training alters iron metabolism and evaluate its correlation with the inflammatory markers and bone-morphogenesis.
- Establish, whether muscle-released irisin signals growth in the BDNF concentration in response to exercise and if these changes improve cognitive function.
- Establish, whether Nordic Walking or HIIT training effectively improve the blood lipid profile and aerobic capacity, and if these effects correlate with the blood 25-OHD concentration.
- Establish, whether concentration of vitamin D alters adaptation to training and modifies immunological response to regular training process.
Detailed description
The mechanism behind the anti-inflammatory effect of exercise is not fully understood. In some cases physical activity has proven almost/completely ineffective in reducing systemic inflammation. Thus, evaluating factors, which modify this response, is of particular significance. One of them may be related to iron metabolism. It is has been suggested that regular training reduces body iron stores, which can contribute to the anti-inflammatory response. Consequently, one of the anti-inflammatory effects of exercise can be related to changes in iron metabolism. Nevertheless, our preliminary data demonstrated that eight months of Nordic Walking training did not reduce body iron stores in approx. 25% of subjects, even if some of them were characterized by high blood ferritin (good indicator of body iron stores). This may be related to the effect of exercise on the concentration of hepcidin (main regulator of iron absorption, which acts as a negative regulator of iron efflux). It is well documented that a single bout of exercise induces an increase in blood hepcidin; however, data on the effect of regular training on the hepcidin concentration are limited.
Vitamin D is another factor, which could influence the anti-inflammatory effect of exercise. It has been suggested that individuals involved in physical activity have higher concentrations of 25OHD (indicator of vitamin D status). Vitamin D inhibits the expression of pro-inflammatory cytokines, which is considered the main mechanism of its anti-inflammatory action. It is worth noting that population in Poland is characterized by low status of vitamin D. Thus, it is possible that the anti-inflammatory effect of exercise will be modified by the vitamin status. Moreover, vitamin D has been shown to protect against muscle atrophy both in elderly and younger people. Its concentration has been correlated with muscle strength.
Inflammation has been observed to be associated with an increase of the autophagy-inducing stress protein, HMGB1, which mediates muscle atrophy. Measurement of plasma amino acid profile will be helpful to assess the impact of exercise on muscle proteolysis. Moreover, the link between exercise, vitamin D status and HMGB1 has not yet been established. In addition, a range of interactions induced by exercise involves the release of the newly discovered protein, irisin, form the muscle and its improving effect on the cognitive function through the synthesis of brain-derived neurotrophic factor (BDNF). Data on the effect of regular training on irisin concentration in elderly people is lacking.
Overall, our research interest focuses on the role of the factors mediating the anti-inflammatory effect of exercise and the way they stimulate or inhibit adaptive changes. The proposed project draws on our long experience in investigating the effects of exercise on iron metabolism as well as other physical methods supporting the anti-inflammatory action of physical activity. Latest published papers indicate that the concentration of vitamin D, also in training adaptation, can modulate immunological response to exercise. Therefore, verifying our hypothesis would also allow us to determine if the concentration of vitamin D can limit adaptation to physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Model I Women and men over 65 years old will participate in the training programme. All subjects will undergo a medical check-up before being subject to exercise. All procedures will be performed with the approval from the Bioethical Committee of the Regional Medical Society in Gdansk. One week prior to the beginning of the experiment, a battery of physiological and psychological tests will be performed. The same procedure will be repeated after the training period. In addtition to training, supplementation of vitamin D (800IU and 4000IU) will be administered. Model II Young women will participate in the training programme. They will perform a high-intensity circuit training according to the ACSM. They will perform a single session of HICT and 12 units of HICT regularly. One week prior to the beginning of the experiment, a battery of physiological and psychological test will be performed. The same procedure will be repeated after the training period.
| Arm | Type | Receives |
|---|---|---|
| Training NW | Experimental | Dietary Supplement: NW training, Dietary Supplement: Placeboexercise and supplementation |
| Training HICT and vitamin D | Experimental | Dietary Supplement: NW training, Dietary Supplement: Placebo, Dietary Supplement: HICTTraining HICT plus vitamin D |
| Placebo | Experimental | Dietary Supplement: NW trainingplacebo Vitamin D |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- no illness medical check
Key exclusion criteria (1 listed)
- uncontrolled hypertension (diastolic blood pressure over 100 mmHg), a history of cardiac arrhythmia, cardio-respiratory disorders, advanced osteoporosis, clinical diagnosis of Alzheimer's Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NW trainingAlso: Training, vitamin DNW training | Dietary supplement | Placebo, Training HICT and vitamin D, Training NW |
| PlaceboAlso: Control grouptraining with placebo | Dietary supplement | Training HICT and vitamin D, Training NW |
| HICTAlso: resistance trainingTraining and vitamin D | Dietary supplement | Training HICT and vitamin D |
Primary outcome
The influence of vitamin D on physical performance in aging people
Time frame: Values at baseline will be compared to values recorded 12 weeks and 3 months after the training programme.
To verify if training supported by vitamin D supplementation will bring better effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Results publication: PubMed 28316011Gmiat A, Mieszkowski J, Prusik K, Prusik K, Kortas J, Kochanowicz A, Radulska A, Lipinski M, Tomczyk M, Jaworska J, Antosiewicz J, Ziemann E. Changes in pro-inflammatory markers and leucine concentrations in response to Nordic Walking training combined with vitamin D supplementation in elderly women. Biogerontology. 2017 Aug;18(4):535-548. doi: 10.1007/s10522-017-9694-8. Epub 2017 Mar 18.
- Results publication: PubMed 29515518Prusik K, Kortas J, Prusik K, Mieszkowski J, Jaworska J, Skrobot W, Lipinski M, Ziemann E, Antosiewicz J. Nordic Walking Training Causes a Decrease in Blood Cholesterol in Elderly Women Supplemented with Vitamin D. Front Endocrinol (Lausanne). 2018 Feb 20;9:42. doi: 10.3389/fendo.2018.00042. eCollection 2018.
- Results publication: PubMed 30241318Walentukiewicz A, Lysak-Radomska A, Jaworska J, Prusik K, Prusik K, Kortas JA, Lipinski M, Babinska A, Antosiewicz J, Ziemann E. Vitamin D Supplementation and Nordic Walking Training Decreases Serum Homocysteine and Ferritin in Elderly Women. Int J Environ Res Public Health. 2018 Sep 20;15(10):2064. doi: 10.3390/ijerph15102064.
- Results publication: PubMed 30205445Mieszkowski J, Niespodzinski B, Kochanowicz A, Gmiat A, Prusik K, Prusik K, Kortas J, Ziemann E, Antosiewicz J. The Effect of Nordic Walking Training Combined with Vitamin D Supplementation on Postural Control and Muscle Strength in Elderly People-A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Sep 7;15(9):1951. doi: 10.3390/ijerph15091951.
- Results publication: PubMed 29432893Gmiat A, Jaworska J, Micielska K, Kortas J, Prusik K, Prusik K, Lipowski M, Radulska A, Szupryczynska N, Antosiewicz J, Ziemann E. Improvement of cognitive functions in response to a regular Nordic walking training in elderly women - A change dependent on the training experience. Exp Gerontol. 2018 Apr;104:105-112. doi: 10.1016/j.exger.2018.02.006. Epub 2018 Feb 9.
- Results publication: PubMed 28229255Kortas J, Kuchta A, Prusik K, Prusik K, Ziemann E, Labudda S, Cwiklinska A, Wieczorek E, Jankowski M, Antosiewicz J. Nordic walking training attenuation of oxidative stress in association with a drop in body iron stores in elderly women. Biogerontology. 2017 Aug;18(4):517-524. doi: 10.1007/s10522-017-9681-0. Epub 2017 Feb 22.
- Individual participant dataSharing planned: No. Written-up results of research will be submitted for publication to international journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Ziemann principal investigator
Gdansk University of Physical Education and Sport, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NW training and HICT in people with Vitamin D3 Deficiency, run by Gdansk University of Physical Education and Sport at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influence of vitamin D on physical performance in aging people (time frame: Values at baseline will be compared to values recorded 12 weeks and 3 months after the training programme.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03417700, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.